Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia

Duke University

Status and phase: Begins enrollment this month; Phase 4

Conditions: Knee Stiffness After Total Knee Arthroplasty

Treatments: Procedure: General Anesthesia; Procedure: Spinal Anesthesia; Drug: Propofol; Drug: Chloroprocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07348614

Pro00118605

Details and patient eligibility

About

The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

1. Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
2. ASA Classification I - III.
3. English speaking patients.

Exclusion:

1. ASA 4 or 5

2. Daily chronic opioid use (over 3 months of continuous opioid use).

3. Inability to communicate pain scores or need for analgesia.

4. Infection at the site of block placement

5. Age under 18 years old or greater than 75 years old

6. Pregnant women (as determined by point-of-care serum bHCG)

7. Intolerance/allergy to local anesthetics

8. Weight <50 kg

9. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.

11. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

12. BMI >50 kg/m2.

13. Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen

    (NSAIDs and acetaminophen)

14. Contraindication to spinal injection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Spinal Anesthesia

Experimental group

Description:

Patients receive spinal anesthesia during MUA (manipulation under anesthesia).

Treatment:

Drug: Chloroprocaine

Procedure: Spinal Anesthesia

General Anesthesia

Active Comparator group

Description:

Patients receive general anesthesia during MUA (manipulation under anesthesia).

Treatment:

Drug: Propofol

Procedure: General Anesthesia